1. Industry stakeholder follow-up meeting, 23 June 2015 Agenda topic 5
03 September 2018
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports
Industry stakeholder follow-up meeting, 23 June 2015
Agenda topic 5
Presented by Anne-Sophie Henry-Eude
Head of Access to Documents Service

2. Introduction The purpose of this guidance is to clarify:
How to identify and mark in the documents the proposed CCI redactions
What is the expected justification level of detail that would allow the Agency to perform an adequate and informed assessment of the proposed redactions
How to apply the redaction principles laid out in Policy 0070
The ultimate goals of the guidance
to ensure a common understanding of what can or cannot be considered CCI within clinical reports
to increase consistency in the proposed and accepted redactions across the range of clinical reports
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

3. Contents Documents subject to publication Justification table
Information that is not considered CCI
Information that may be considered CCI
Justification – expected level of detail
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

4. Documents subject to publication
03 September 2018
Documents subject to publication
Clinical overviews (generally submitted in module 2.5)
Clinical summaries (generally submitted in module 2.7 – sections to 2.7.4)
Clinical study reports (CSRs) (generally submitted in module 5 - section 5.3*) together with the following appendices as  defined in ICH E3:
(protocol and protocol amendments)
(sample case report form)
(documentation of statistical methods)
*The Agency would like to emphasize that although other type of reports may be found in section 5.3, the subject of this policy is restricted to the publishing clinical study reports only (CSR), excluding for example PSURs submitted usually in and Case report form and individual patient listing submitted usually under section
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

5. Justification table (1/2)
A living document that will reflect the justifications put forward by the company and the Agency’s conclusions
A separate justification table for each of the clinical reports
Will be used as a communication tool between the Agency and the company during the redaction consultation process
Submitted as word document
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

6. Justification table (2/2)
03 September 2018
Justification table (2/2)
Each table should list all proposed CCI redactions
Each table should be fully completed by the Applicants/MAHs
The justification table is not part of the documents to be published
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

7. Information that is not considered CCI (1/3)
03 September 2018
Information that is not considered CCI (1/3)
Information available in the public domain from various sources*
Company website
Scientific guidelines
Clinical trial registries
Websites of other regulatory authorities within and outside of the EU
Scientific literature and articles (such as Textbooks, PubMed, Medline)
Patent application
*The information sources listed above should be checked as the minimum number of sources and are not meant to constitute an exhaustive list
Rejection code: CCI - Rejection 01 – Public Information 
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

8. Information that is not considered CCI (2/3)
03 September 2018
Information that is not considered CCI (2/3)
Information that does not bear any innovative features
Information reflecting common knowledge shared within the scientific community via:
Scientific literature and articles (Textbooks, PubMed, Medline)
Scientific and regulatory guidelines and guidance documents
Treatment guidelines
Rejection code: CCI - Rejection 02 – Public knowledge
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

9. Information that is not considered CCI (3/3)
03 September 2018
Information that is not considered CCI (3/3)
Information that, in the Agency’s view, does not constitute CCI
General or administrative information: names of all CROs and vendors
Some/Certain quality related information: temperature, humidity parameters and storage duration as applied in stability tests
Non-Clinical related information: quantification range (lower and upper quantification limits) of pharmacokinetic and pharmacology tests/methods; information concerning a generally-used/well- known immunohistochemistry method (e.g. ELISA/LC-MS)
Clinical related information: statistical methods (including imputation methods used for missing data); protocol and protocol amendments
Rejection code: CCI - Rejection 03 – Public interest
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

10. Information that may be considered CCI
03 September 2018
Information that may be considered CCI
Has to fall under the types of information that may potentially be considered CCI according to Policy 0070 Annex III
Has to be adequately justified
Justifications solely based on annex III justification text or referring to annex III information types will not be considered relevant, therefore will be rejected
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

11. Justification – expected level of detail (1/3)
The applicants are expected to submit a specific, pertinent, relevant, not overstated and appropriate justification for each of the pieces of text proposed to be redacted
The justification wording has to meet the following criteria:
Clearly refer to/identify the information proposed to be redacted
Highlight the innovative features of the information in the context of the public knowledge within the specific scientific area
Explicitly indicate to which on-going development programme the information relates to
Explain how the disclosure of the concerned information would undermine the applicant’s/MAH’s economic interest or competitive position
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

12. Justification – expected level of detail (2/3)
If Agency considers the justification insufficient additional clarifications are requested
Whenever the Agency considers that the justification is not sufficiently specific or too vague, the following rejection codes will be included in the justification table:
CCI – Rejection 04 – Insufficient justification
CCI - Rejection 05 – Irrelevant justification
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

13. Justification – expected level of detail (3/3)
Justifications that will be considered by the Agency either insufficient or irrelevant:
“Information is commercially confidential, competitively sensitive information and includes intellectual property including trade secret information.”
“The text proposed to be redacted reveals purpose and timing of discussions with health authorities, this is considered sensitive information that is not consolidated in this way within the public domain, indeed we cannot find this information in public forum.”
“Company confidential information - Disclosure of these elements will harm <company>’s commercial interests because it may enable third party access to business-critical information.”
“Information on the safety profile of the product not reflected in the SmPC.”
“This information can be interpreted out of context. Such interpretation could lead to a misleading image of the safety profile of the product.”
Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports

14. Thank you for your attention
03 September 2018
Thank you for your attention
Further information
European Medicines Agency
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